FDA pre-note enforcement to step up in March

TORONTO, (Feb. 27, 2004) — In two weeks the U.S. Food and Drug Administration’s pre-notification and food facility registration rules will enter into the second phase of enforcement under the Public Health Security and Bioterrorism Preparedness and Response Act.

On March 13, the second phase of an eight-month implementation plan will kick-in under the classification titled Informed Compliance and Penalties for Egregious Violators. The yet-to-be determined penalties will be assessed to those parties who have a history of being continuously warned for not abiding by the prior notice requirements since the rules took effect on Dec. 12, 2003. Penalties will also be assessed if the violations for failure to provide prior notice appear to be intentional or flagrant.

The rules require domestic and foreign food facilities that manufacture, process, pack or hold food to electronically notify FDA of food shipments two hours before it reaches the border. The rule also requires such parties to register with the agency. However, carriers hauling food cargo between two points do not have to register equipment like trucks and trailers provided the company does not “process or sort food” en route.

The third stage will commence May 13, and the complete phase of enforcement under the new regulations will begin August 12, 2004. Once the regulations are being fully enforced at U.S. ports of entry, failure to comply will result in trucks being turned around, held at the crossing, or sent to secure offsite facilities. The Ontario Trucking Association says it is monitoring the implementation process and will release more information of the next phase as it becomes available.

For additional information on the upcoming phases of enforcement, refer to the attached Compliance Policy Guide Guidance for FDA and CBP Staff or the following link: http://www.cfsan.fda.gov/~pn/cpgpn.html.